ACCLARENT RECEIVES FDA CLEARANCE FOR EXPANDED INDICATION
OF ACCLARENT AERA EUSTACHIAN TUBE BALLOON DILATION SYSTEM
Procedures May Now Be Performed on Patients as Young as 18, New Data on Local Anesthesia Also Recognized
IRVINE, CA – February 27, 2018 – Johnson & Johnson Medical Devices Companies* today announced that Acclarent, Inc., a leader in developing minimally-invasive Ear, Nose & Throat (ENT) technologies, has received clearance from the U.S. Food and Drug Administration (FDA) to expand the indication for the Acclarent AERA® Eustachian Tube Balloon Dilation System to include its use in patients as young as 18.¹ The device was previously cleared only for adults aged 22 and older.
In addition, recent evidence shows the procedure may be performed with local and/or topical anesthesia – before, only general anesthesia had been studied.1,2 The use of local anesthesia may provide benefits including cost savings and time efficiencies for suitable patients.
Eustachian Tube Dysfunction (ETD) is a blockage of the narrow tube that connects the throat to the middle ear, and helps the ears drain fluid and equalize pressure. The condition, which affects up to 5 percent of adults,³ is often marked by ear pain, pressure in the ears, and dulled or loss of hearing. Previously, ETD was treated with medication, or surgery with ear tubes. However, failure to correct the underlying problem may lead some patients to develop chronic symptoms, persistent complaints or more serious conditions such as middle ear effusion, infections and related long-term complications.
Acclarent AERA ® is the first and only device specifically designed to help treat patients with persistent ETD. The device leverages flexible technology to adapt to variations in ear anatomy to help ear, nose and throat surgeons minimize trauma through precise access and positioning. More than 9,000 patients have been treated with the Acclarent AERA® since it was first granted clearance by the FDA in 2016.⁴
“This expanded indication of Acclarent AERA® , and the data regarding the procedure under local anesthesia, will help expand treatment options and bring relief to more patients with persistent ETD,” said Dr. Marc Dean, a board-certified otolaryngologist in private practice and the cofounder and chairman of the Vitruvio Institute for Medical Advancement in Fort Worth, Texas. “The device provides a minimally invasive option for ear, nose and throat surgeons to treat persistent ETD at its source.”
Results from a recent clinical study demonstrated a 99.7 percent technical success rate in Eustachian tubes dilated with the Acclarent AERA® device. Additionally, there were zero reported serious device- or procedure-related adverse events,5 and patients reported greater improvement in quality of life measures.
See how the device works here: https://www.youtube.com/watch?v=hJMort6YCI4
About the Johnson & Johnson Medical Devices Companies
The Johnson & Johnson Medical Devices Companies* have been working to make surgery better for more than a century. With substantial breadth and depth in surgical and orthopedic technologies and interventional solutions, we aspire to improve and enhance medical care for people worldwide. Together, we are working to shape the future of health through differentiated products and services.
About Acclarent, Inc.
Acclarent, Inc., part of Johnson & Johnson Medical Devices Companies, is located in Irvine, CA. Its singular focus is to free patients to live better lives by designing, developing and commercializing medical devices that address conditions affecting the ear, nose and throat. For more than a decade, Acclarent has led the field in delivering innovative technologies to ENT surgeons. For more information, visit www.acclarent.com
*Comprising the surgery, orthopedics, and cardiovascular businesses within Johnson & Johnson’s Medical Devices segment
Caution: Federal (U.S.) law restricts the sale, distribution or use of the ACCLARENT AERA® by or on the order of a physician who is trained in the use of Acclarent technology. Eustachian tube balloon dilation has associated risks, including tissue and mucosal trauma, infection, or possible carotid artery injury. Prior to use, it is important to read the Instructions for Use and to understand the contraindications, warnings, and precautions associated with these devices.
ACCLARENT AERA® is intended for use by physicians who are trained on Acclarent technology. Eustachian tube balloon dilation has associated risks, including tissue and mucosal trauma, infection, or possible carotid artery injury. Prior to use, it is important to read the Instructions for Use and to understand the contraindications, warnings, and precautions associated with these devices.
1 Acclarent IFU005146 Rev E, Acclarent AERA® Eustachian Tube Balloon Dilation System instructions for Use. 2018
² Luukkainen V, Kivekäs I, Hammarén-Malmi S, Rautiainen M, Pöyhönen L, Aarnisalo AA, Jero J, Sinkkonen ST. Balloon Eustachian tuboplasty under local anesthesia: Is it feasible? Laryngoscope. 2017 Feb 03. doi:10.1002/lary.26488
³ Ockermann, T., Reineke, U., Upile, T., Ebmeyer, F., Sudhoff, H.H. (2010). Balloon Dilatation Eustachian Tuboplasty: A Clinical Study. Laryngoscope, 120:1411–1416.
⁴ Acclarent AERA® Procedure Data Documented on January 18, 2018
⁵ Poe D, Anand V, Dean M, Roberts WH, Stolovitzky JP, Hoffmann K, Nachlas NE, Light JP, Widick MH, Sugrue JP, Elliott CL, Rosenberg SI, Guillory P, Brown N, Syms CA 3rd, Hilton CW, McElveen JT Jr, Singh A, Weiss RL Jr, Arriaga MA, Leopold JP. Balloon dilation of the Eustachian tube for dilatory dysfunction: A randomized controlled trial. Laryngoscope. 2017 Sep 20. doi: 10.1002/lary.26827